510(k) K230651

Device
BD BBL? Sensi-Disc? Lefamulin 20µg (LMU-20)
Applicant
Becton, Dickinson and Company
510(k) number
K230651
Product code
JTN
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-07
Date received
2023-03-09
Regulation
866.1620
Classification name
Susceptibility Test Discs, Antimicrobial
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Katherine Cicala
Address
7loveton Cir. Sparks MD US 21152 21152

FDA Registration Numbers

Source Documents

510(k) summary PDF

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